VIC-1911 Combined With Osimertinib for EGFR-TKI Mutant Non-small Cell Lung Cancer
Status:
Not yet recruiting
Trial end date:
2024-04-24
Target enrollment:
Participant gender:
Summary
This is a nonrandomized, open phase I dose escalation and extension clinical study designed
to evaluate Aurora A inhibitor VIC-1911 tablets in combination with oxitinib in Chinese
patients with advanced non-small cell lung cancer The safety, tolerability, pharmacokinetic
characteristics and preliminary antitumor efficacy were analyzed.
The entire study included the screening period (28 days prior to initialadministration of the
investigational drug) and the treatment period (Cycle) EoT is defined as disease progression
or intolerable toxicity or premature withdrawal Out]) and the safety follow-up period (28
days after EoT). During dose increments and expansions, subjects followed Safety assessment,
PK blood collection, imaging examination and efficacy assessment were performed during the
visit plan. Observation subject The safety, tolerability, and occurrence of DLT until disease
progression, occurrence of intolerable toxicity, Death, withdrawal of informed consent, loss
of follow-up or termination of the study by the sponsor shall prevail.